Biopsy device with rotatable tissue sample holder

ABSTRACT

A biopsy device comprises a probe body, a cannula extending distally from the probe body, a cutter moveable relative to the cannula to sever tissue, and a tissue sample holder coupled with the probe body. The tissue sample holder comprises a rotatable member having a plurality of recesses to receive tissue samples. The rotatable member can be operable to successively index each recess relative to a lumen defined by the cutter. A cover portion may be associated with the rotatable member and permits one or more recesses to be viewable through the cover. The recesses may be configured to carry one or more tissue samples as the rotatable member is rotated.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of co-pending andcommonly-owned U.S. patent application Ser. No. 12/686,433, entitled“BIOPSY DEVICE WITH ROTATABLE TISSUE SAMPLE HOLDER,” filed Jan. 13,2010, which is a continuation of U.S. Pat. No. 7,854,707, entitled“TISSUE SAMPLE REVOLVER DRUM BIOPSY DEVICE,” issued Dec. 21, 2010, thedisclosures of which are hereby incorporated by reference in theirentirety.

U.S. Pat. No. 7,854,707 is a continuation-in-part of commonly-owned U.S.Pat. No. 7,867,173, entitled “BIOPSY DEVICE WITH REPLACEABLE PROBE ANDINCORPORATING VIBRATION INSERTION ASSIST AND STATIC VACUUM SOURCE SAMPLESTACKING RETRIEVAL,” issued Jan. 11, 2011, the disclosure of which ishereby incorporated by reference in its entirety.

U.S. Pat. No. 7,854,707 also claims priority to U.S. Pat. Appln. Ser.No. 60/874,792, entitled “BIOPSY SAMPLE STORAGE” to Hibner et al., filedDec. 13, 2006, the disclosure of which is hereby incorporated byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates in general to biopsy devices, and moreparticularly to biopsy devices having a cutter for severing tissue, andeven more particularly to biopsy devices for multiple sampling with aprobe remaining inserted.

BACKGROUND OF THE INVENTION

When a suspicious tissue mass is discovered in a patient's breastthrough examination, ultrasound, MRI, X-ray imaging or the like, it isoften necessary to perform a biopsy procedure to remove one or moresamples of that tissue in order to determine whether the mass containscancerous cells. A biopsy may be performed using an open or percutaneousmethod.

An open biopsy is performed by making a large incision in the breast andremoving either the entire mass, called an excisional biopsy, or asubstantial portion of it, known as an incisional biopsy. An open biopsyis a surgical procedure that is usually done as an outpatient procedurein a hospital or a surgical center, involving both high cost and a highlevel of trauma to the patient. Open biopsy carries a relatively higherrisk of infection and bleeding than does percutaneous biopsy, and thedisfigurement that sometimes results from an open biopsy may make itdifficult to read future mammograms. Further, the aestheticconsiderations of the patient make open biopsy even less appealing dueto the risk of disfigurement. Given that a high percentage of biopsiesshow that the suspicious tissue mass is not cancerous, the downsides ofthe open biopsy procedure render this method inappropriate in manycases.

Percutaneous biopsy, to the contrary, is much less invasive than openbiopsy. Percutaneous biopsy may be performed using fine needleaspiration (FNA) or core needle biopsy. In FNA, a very thin needle isused to withdraw fluid and cells from the suspicious tissue mass. Thismethod has an advantage in that it is very low-pain, so low-pain thatlocal anesthetic is not always used because the application of it may bemore painful than the FNA itself. However, a shortcoming of FNA is thatonly a small number of cells are obtained through the procedure,rendering it relatively less useful in analyzing the suspicious tissueand making an assessment of the progression of the cancer less simple ifthe sample is found to be malignant.

During a core needle biopsy, a small tissue sample is removed allowingfor a pathological assessment of the tissue, including an assessment ofthe progression of any cancerous cells that are found. The followingpatent documents disclose various core biopsy devices and areincorporated herein by reference in their entirety: U.S. Pat. No.6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15,2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No.6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11,2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No.6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28,1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No.5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27,1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No.5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22,1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US PatentApplication 2003/0199753 published Oct. 23, 2003 to Hibner et al.

At present, a biopsy instrument marketed under the trade name MAMMOTOMEis commercially available from DEVICOR MEDICAL PRODUCTS, INC. for use inobtaining breast biopsy samples. This device generally retrievesmultiple core biopsy samples from one insertion into breast tissue withvacuum assistance. In particular, a cutter tube is extended into a probeto cut tissue prolapsed into a side aperture under vacuum assistance andthen the cutter tube is fully retracted between cuts to extract thesample.

With a long probe, the rate of sample taking is limited not only by thetime required to rotate or reposition the probe but also by the timeneeded to translate the cutter. As an alternative to this “long stroke”biopsy device, a “short stroke” biopsy device is described in thefollowing commonly assigned patents and patent applications: U.S. Pat.No. 7,419,472, entitled “Biopsy Instrument with Internal SpecimenCollection Mechanism,” issued Sep. 2, 2008 in the name of Hibner et al.;and U.S. Pat. No. 7,740,597, entitled “Biopsy Device with Sample Tube,”issued Jun. 22, 2010 in the name of Cicenas et al. The cutter is cycledacross the side aperture, reducing the sample time. Several alternativespecimen collection mechanisms are described that draw samples throughthe cutter tube, all of which allow for taking multiple samples withoutremoving the probe from the breast.

In particular, in the cross referenced U.S. Pat. Pub. No. 2006/0074345,entitled “BIOPSY APPARATUS AND METHOD”, these tissue samples are drawnby vacuum proximally through the cutter tube into a serial tissuestacking assembly that preserves the order of sample taking, can bevisually observed through a transparent lumen, and can serve as atransport container for samples taken during a pathology examination.

While these known tissue storage approaches have a number of advantages,it is believed that further improvements may be made in tissue storageand transport for core biopsy procedures.

SUMMARY OF THE INVENTION

The present invention addresses these and other problems of the priorart by providing a biopsy device that has a probe cannula that isinserted into tissue to obtain a core biopsy sample by translating acutter with the probe cannula. A pneumatic pressure differential is usedto draw a severed tissue sample proximally from the probe cannula intoan individual sample container. Thereafter, another empty samplecontainer is moved into position to accept the next tissue sample.

These and other objects and advantages of the present invention shall bemade apparent from the accompanying drawings and the descriptionthereof.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed the samewill be better understood by reference to the following description,taken in conjunction with the accompanying drawings in which:

FIG. 1 is an isometric view of a biopsy device with an attached samplerevolver drum assembly consistent with the present invention.

FIG. 2 is an isometric view of the biopsy device of FIG. 1 with adisposable probe assembly that includes the sample revolver drumassembly disengaged from a reusable handpiece that has a lower trayremoved to expose a carriage frame assembly and a motor drive assembly.

FIG. 3 is an isometric view of the reusable handpiece of FIG. 1 with atop cover detached with a left half cut away and with the lower handletray detached to expose the motor drive assembly operatively engaged tothe carriage frame assembly.

FIG. 4 is an isometric view of the motor drive assembly removed from thecarriage frame assembly of FIG. 3.

FIG. 5 is a bottom isometric view of the top cover of the reusablehandpiece of FIG. 2.

FIG. 6 is a top, left and aft isometric view of the carriage frameassembly of FIG. 4.

FIG. 7 is a top, left and forward view of the carriage frame assembly ofFIG. 4 with an upper frame disassembled.

FIG. 8 is a top, left and front isometric view of the carriage frameassembly of FIG. 4 with the upper frame removed.

FIG. 9 is a bottom isometric view of the carriage frame assembly of FIG.8 with the upper frame removed.

FIG. 10 is a top, left and front isometric exploded view of the carriageframe assembly of FIG. 4.

FIG. 11 is a right front view of a transmission section of the motordrive assembly of FIG. 4 with a distal bulkhead removed.

FIG. 12 is a front left exploded view of the transmission section of themotor drive assembly of FIG. 4.

FIG. 13 is a left front isometric view of the disposable probe assemblyof FIG. 1 with a hand-held distal portion partially disassembled fromthe sample revolver drum assembly.

FIG. 14 is an isometric view from below and to the left of the hand-helddistal portion of the disposable probe assembly of FIG. 13 with covercomponents omitted.

FIG. 15 is an isometric view of an exploded portion of the disposableprobe assembly.

FIG. 16 is an isometric view of the sample revolver drum assembly ofFIG. 1.

FIG. 17 is an exploded view of the sample revolver drum assembly of FIG.16.

FIG. 18 is an isometric detail view of an indexer gear cover of thesample revolver drum assembly of FIG. 16.

FIG. 19A is a left side diagrammatic view of a left cyclic arm shown inphantom down for engagement during a proximal stroke engaged to theindexer gear cover of FIG. 18.

FIG. 19B is a left side diagrammatic view of the left cyclic arm shownin phantom at a proximal most position on the indexer gear cover of FIG.18.

FIG. 19C is a left side diagrammatic view of the left cyclic arm shownin phantom during a return distal stroke rotated upward fordisengagement.

FIG. 20 is an isometric view of a revolver cylindrical drum assembly ofthe sample revolver drum assembly of FIG. 16.

FIG. 21 is an isometric view of the revolver cylindrical drum of therevolver cylindrical drum assembly of FIG. 20.

FIG. 22 is an isometric view of a revolver drum belt with a couple ofremoved sample vials of the revolver cylindrical drum assembly of FIG.20.

FIG. 23 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with both carriages advanced forclosing a side aperture in a probe cannula for insertion into tissue.

FIG. 24 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with an aft carriage retracted tovent the probe cannula to the atmosphere to begin a new sample takingcycle.

FIG. 25 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with a front carriage beginning toretract, opening the side aperture and beginning to switch to supplyingvacuum to the probe cannula.

FIG. 26 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with both carriages retractedsupplying vacuum pressure to the side aperture to prolapse tissue intothe probe cannula.

FIG. 27 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with the front carriage beingdistally advanced to sever tissue.

FIG. 28 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with the front carriage fullydistally translated to complete severing of a tissue sample withatmosphere pressure supplied to the side aperture through a laterallumen.

FIG. 29 is a diagrammatic view of the hand-held distal portion of thedisposable probe assembly of FIG. 1 with the aft carriage distallyadvanced to retract the tissue sample with vacuum pressure.

DETAILED DESCRIPTION OF THE INVENTION

Turning to the Drawings, wherein like numerals denote like componentsthroughout the several views, in FIGS. 1-2, a biopsy device 10 includesa reusable handpiece 12, and a disposable probe assembly 14. A lowerhandle tray 16 is disassembled from upper portions of the reusablehandpiece 12 to expose portions that operably engage the disposableprobe assembly 14. A sample revolver drum assembly 18 is prepared toreceive the next tissue sample by an indexing assembly 19 attached to ahand-held distal portion 21 of the disposable probe assembly 14 thatmounts to and is actuated by the reusable handpiece 12. Tissue that isdrawn by vacuum assistance into a side aperture 20 of a probe cannula 22of the disposable probe assembly 14 is severed by a DC motor 24 (FIG. 3)in the reusable handpiece 12 that also powers rotation and staging ofthe sample revolver drum assembly 18 to segregate and store the tissuesamples in the order received.

With particular reference to FIG. 1, insertion of the probe cannula 22into tissue is integrally supported by a piercing tip 26 attached at adistal end as well as a longitudinal jack hammer motion to the probecannula 22 selected by positioning a slide button 28 distally anddepressing a forward motor button 30. In response, the DC motor 24drives a transmission section 31 (FIG. 2) grounded to a top cover 34 ofthe reusable handpiece 12 to longitudinally reciprocate an internalcarriage frame assembly 32 (FIG. 2) that is engaged for movement withthe probe cannula 22 (FIG. 3). With the slide button 28 proximallypositioned, depression of the forward motor button 30 causes the DCmotor 24 to advance and rotate a cutter tube 36, depicted in FIG. 1 ashaving been fully distally translated, closing the side aperture 20.Depression of a reverse motor button 38 causes the cutter tube 36 toretract. Depression of a mode button 40 may cause other functions to beperformed. An external conduit 42 extends from the disposable probeassembly 14 and is terminated by a filter/tube fitting 43. Vacuumassistance passes through a lateral lumen 44 of the probe cannula 22 anddistally communicates via internal vent holes 47 (FIG. 23) and thenenters a cutter lumen 46 that encompasses the cutter tube 36 andincludes the side aperture 20. An additional feature contemplated butnot depicted includes using the mode button 40 to selectivelycommunicate a saline supply to lateral lumen 44 to flush the probecannula. It should be appreciated that the biopsy device 10 includes aminimum of “tethers” that would impede use, pose a tripping hazard, orextend set-up time.

Alternatively, instead of “hard-walled” lateral lumen 44 separated fromthe cutter lumen 46 along its length, applications consistent with thepresent invention may have a cylindrical probe cannula wherein thecutter tube 36 is positioned off-center to translate across a sideaperture. A “soft-walled” lateral lumen may then be defined as a spacebetween an outer diameter of the cutter tube and an inner diameter ofthe cylindrical probe cannula.

In FIG. 2, the disposable probe assembly 14 has a bottom cover 48 with adistal probe mount cover 50 that assists in supporting the probe cannula22 while allowing the longitudinal jack hammer motion. A plurality oflocking tabs 52 with locking edges 54 extend upwardly throughpass-through slots 56 formed in the periphery of the lower handle tray16 to resiliently extend outwardly into engaging contact with the slots56. Relieved areas 58 are formed behind each locking tab 52 in a topextension member 59 that surrounds a probe support body 60. Thecombination covers a cavity defined by the bottom cover 48, which allowsdepression of the locking tabs 52 to unlock the disposable probeassembly 14 to install another identical or similar assembly.

A proximal end of the cutter tube 36 receives a cutter gear 62 havingdistal and proximal reduced diameter bearing surfaces 64, 66 on eachlongitudinal side of a rotation spur gear section 68, which engage thereusable handpiece 12 for rotation and for longitudinal translationthrough a distally open longitudinal aperture 70 formed in the lowerhandle tray 16.

REUSABLE HANDPIECE. In FIGS. 3-13, the reusable handpiece 12 is depictedin various states of disassembly to illustrate its operation. Thetransmission section 31 is part of a rigidly mounted motor driveassembly 76 that includes the motor 24 in between a planetary gearbox 78and an encoder 80. The battery or other power source and controlcircuitry are omitted in the depictions. The motor drive assembly alsoincludes a right guide pin 82 and a left guide pin 84. The motor driveassembly 76 is shown operably engaged to the longitudinallyreciprocating carriage frame assembly 32 in FIG. 3 and is disassembledfrom the longitudinally reciprocating carriage frame assembly in FIG. 4.In FIG. 4, the right guide pin 82 is inserted proximally through a rightfront pin guide 86 and then through a right rear pin guide 88, both partof an upper frame 90 of the carriage frame assembly 32. A proximal endof the right guide pin 82 resides within a distally projecting right pinreceptacle 92 (FIG. 12) formed as part of a distal bulkhead 94 of thetransmission section 31. A distal end of the right guide pin 82 isreceived by a right pin recess 96 (FIG. 5) formed in the top cover 34.Similarly, the left guide pin 84 is inserted proximally through a leftfront pin guide 98 and then through a left rear pin guide 100, both partof the upper frame 90 of the carriage frame assembly 32. A proximal endof the left guide pin 84 resides within a distally projecting left pinreceptacle 102, respectively formed as part of the distal bulkhead 94 ofthe transmission section 31. A distal end of the left guide pin 84 isreceived by a left pin recess 104 (FIG. 5) formed in the top cover 34.

With particular reference to FIGS. 3, 4, 6, 7 and 12, a right front ringbearing 106 is inserted over a distal portion of the right guide pin 82and is received within a cylindrical recess 108 formed on a distal sideof the right front pin guide 86. A right aft ring bearing 109 isinserted over a proximal portion of the right guide pin 82 and isreceived within a cylindrical recess 111 (FIG. 6) formed on a proximalside of the right aft pin guide 88. A left front ring bearing 110 isinserted over a distal portion of the left guide pin 84 and is receivedwithin a cylindrical recess 112 formed on a distal side of the leftfront pin guide 98. A left aft ring bearing 113 (FIG. 9) is insertedover a proximal portion of the left guide pin 84 and is received withina left cylindrical recess 115 (FIG. 6) formed on a proximal side of theleft rear pin guide 100 A right compression spring 114 is proximallyreceived over the right guide pin 82 between the right front and rearpin guides 86, 88. More particularly, the right compression spring 114is distally positioned against the right front pin guide 86 and at itsproximal end by a right downwardly projecting structure 116 (FIG. 5)formed on an interior of the top cover 34 that closely encompasses a topportion of the right guide pin 82 without contacting other portions ofthe carriage frame assembly 32. A left compression spring 118 isproximally received over the left guide pin 84 between the left frontand rear pin guides 98, 100. More particularly, the left compressionspring 118 is distally positioned against the left front pin guide 98 atits distal end by a left downwardly projecting structure 120 (FIG. 5)formed on the interior of the top cover 34 that closely encompasses atop portion of the left guide pin 84 without contacting other portionsof the carriage frame assembly 32. Thereby, the carriage frame assembly32 is biased to a distal position relative to the top cover 34 and lowerhandle tray 16.

In FIGS. 3-5, a forward projecting cylindrical resilient member 122fastened to the upper frame 90 reduces noise by contacting the frontinterior of the top cover 34 slowing distal movement of the carriageframe assembly 32 prior to reaching full travel. The distal bulkhead 94is restrained by being proximal to a top ridge 123, a right ridge 125,and a left ridge 127 (FIG. 5) formed in the interior of the top cover 34and to a bottom ridge 129 formed on an upper surface of the lower handletray 16.

Returning to FIGS. 3-4 and 7, the upper frame 90 has right and leftfront shaft apertures 124, 126 that respectfully receive for rotation adistal end of a rotation shaft 128 and a translation shaft 130. Theright front shaft aperture 124 is closed by the front portion of a rightlower frame 131 of the carriage frame assembly 32. The left front shaftaperture 126 is closed by the front portion of a left lower frame 132 ofthe carriage frame assembly 32. A front (cutter) carriage 134 and an aft(straw) carriage 136 are received on the translation shaft 130 and areencompassed by the upper and lower frames 90, 132. In FIG. 6, a proximalbeveled and slotted end 138 of the rotation shaft 128 extends out ofright aft shaft aperture 140 formed in the upper frame 90 for engagementto the transmission section 31 and is closed by an aft portion of theright lower frame 131. A proximal slotted end 142 of the translationshaft 130 extends out of a left aft aperture 144 formed in the upperframe 90 for engagement to the transmission section 31 and is closed bythe lower frame 132. A threaded receptacle 146 on the aft end of theupper frame 90 receives a proximally projecting bolt 148 having anupwardly directed strike pin 148 at its proximal end.

In FIGS. 7-10, the carriage frame assembly 32 sequences translation ofthe front and aft carriages 134, 136. With particular reference to FIG.10, the front and aft carriages 134, 136 respectively include lowerlongitudinal grooves 152, 154 that slide upon a lower rail 156 upwardlypresented on the left lower frame 132. The front and aft carriages 134,136 respectively include an upper longitudinal groove 158, 160 thatslides upon a rail (not shown) downwardly presented on the upper frame90. The translation shaft 130 has a distal overrun portion 162 and acenter overrun portion 164 separated by a front threaded portion 166that a threaded bore 168 of a front main body portion 169 of the frontcarriage 134 traverses in response to rotation of the translation shaft130. A front translation compression spring 170 on the translation shaft130 distal to the front carriage 134 compresses to allow the frontcarriage 134 to free wheel when being distally advanced and then biasesthe front carriage 134 aft to engage the front threaded portion 166 forbeing retracted upon reversal of rotation of the translation shaft 130.

With particular reference to FIGS. 8 and 10, proximal to the centeroverrun portion 164 is an aft threaded portion 172 and then a proximaloverrun portion 174 that a threaded bore 176 of a back main body portion177 of the aft carriage 136 traverses in response to rotation of thetranslation shaft 130 as well as in response to a connection to thefront carriage 134. In particular, a front bracket 178 mounted on aright side of the front carriage 134 has a rightward front pin guide 180that receives a distal end of a longitudinally aligned carriage limitingrod 182. A distal threaded end 184 of the carriage limiting rod 182extends distally out of the rightward front pin guide 180 and isprevented from backing out by a front nut 186. A long compression spring188 is received over a shaft 190 of the carriage limiting rod 182proximal to the rightward front pin guide 180. An aft bracket 192 isattached to a right side of the back main body portion 177 of the aftcarriage 136 to extend a rightward aft pin guide 194 that receives thecarriage limiting rod 182, which extends a proximal threaded end 196proximally out of the rightward aft pin guide 194 to receive an aft nut198 that limits forward movement. The long compression spring 188 biasesthe aft carriage 136 away from the front carriage 134, delayingretraction of a tissue sample until cutting is complete when full distaltranslation of the front carriage 134 pulls the aft carriage 136 ontothe aft threaded portion 172.

With particular reference to FIG. 9, a lengthwise engagement aperture200, defined between the right and left lower frames 131, 132, presentsengaging structures that actuate the disposable probe assembly 14 andthe revolver drum assembly 18. The rotation (spur) gear 128 exposes itsleft side to the lengthwise engagement aperture 200 for engagement withthe rotation spur gear section 68 of the cutter gear 62 to impart arotation. The front bracket 178 has a downward distal half cylinderrecess 202 sized to grip the distal reduced diameter bearing surface 64of the cutter gear 62 (FIG. 2). The front bracket 178 further has adownward proximal half cylinder recess 204 proximally spaced and sizedto grip the proximal reduced diameter bearing surface 66 of the cuttergear 62 (FIG. 2) as well as a downwardly projecting front actuationfinger 206 to the left side and below of the cutter gear 62 foreffecting atmospheric pressure to the probe cannula 22. Similarly, theaft bracket 192 has a downward distal half cylinder recess 208 and adownward proximal half cylinder recess 210 proximally spaced and sizedto nonobstructively translate overtop of a tissue retraction tube 211,as well as a downwardly projecting aft actuation finger 212 that selectsvacuum pressure for communicating to the probe cannula 22.

In FIGS. 2-3 and 11-12, the motor drive assembly 76 rotates rotation andtranslation shafts 128, 130 at a fixed ratio to optimize cuttingperformance of the cutter tube 36 when the slide button 28 is back.Alternatively, the motor drive assembly 76 imparts a jackhammervibration to the carriage frame assembly 32 when the slide button 28 isforward. With particular reference to FIGS. 11-12, the planetary gearbox78 extends proximally a keyed motor drive shaft 214 (FIG. 12) through adrive shaft hole 216 formed in the distal bulkhead 94. A slide spur gear218 is received upon the keyed motor drive shaft 214 remaining engagedfor rotation between a first distal (jack hammer) position and a secondproximal (translation) position in accordance with a position of theslide button 28 whose distal and proximal feet 220, 222 straddle theslide spur gear 218. In FIG. 11, the slide spur gear 218 is close to aproximal bulkhead 224 of the transmission section 31, engaging a smallspur 226 of a multiplier gear assembly 228. The multiplier gear assembly228 includes a longitudinal shaft 230 centrally attached to the smallspur gear 226. Proximal thereto, a cylindrical hub 232 is pinned to thelongitudinal shaft 230 and in turn is encompassed by and pinned to alarge spur gear 234 that rotates within a correspondingly sized,distally open recess 236 formed in proximally projecting container 237integral to the proximal bulkhead 224. A front cylinder bearing 238received on a distal portion of the longitudinal shaft 230 is receivedby the proximal surface of the distal bulkhead 94.

A first output drive shaft 240 distally presents a right angle prismaticend 242 shaped to engage the beveled and slotted end 138 of the rotationshaft 128 that passes through a lower right hole 244 in the distalbulkhead 94. A cylindrical spacer 246 is received over a distalcylindrical portion 248 of the first output shaft 240, taking up thespace between the rotation shaft 128 and the proximal bulkhead 224. Adistally open recess 250, formed as part of the container 237 thatcommunicates from below with the recess 236, is shaped to receive aproximal cylindrical end 252 of the first output drive shaft 240 andencompasses cylindrical bearing 254 as well as a small spur gear segment256, which is distal thereto and engages the large spur gear 234 of themultiplier gear assembly 228.

A second output drive shaft 258 distally presents a right angleprismatic end 260 to engage the proximal slotted end 142 of thetranslation shaft 130 that extends through a low left hole 262 in thedistal bulkhead 94. A cylindrical spacer 264 is received over a distalcylindrical portion 266 of the second output drive shaft 258 proximal tothe right angle prismatic end 260 and distal to a wider diameter hubsegment 268 that is encompassed by and pinned to a large spur gear 270that engages the small spur gear 226 of the multiplier gear assembly228. Proximal to the hub segment 268 is a wide spacer segment 272 andthen a narrow cylindrical end 274 that receives a cylindrical bearing276 that resides within a correspondingly-sized, distally open recess278 that communicates from the left with the recess 236 and is formed aspart of the same container 237.

The distal and proximal bulkheads 94, 224 are structurally attached toone another in parallel alignment traverse to the longitudinal axis ofthe biopsy device 10 by cylindrical legs 280 molded to and proximallyprojecting from rectangular corners of the distal bulkhead 94 andfastened to the proximal bulkhead 224. In addition, a pin 282 passesthrough holes 281, 283 longitudinally aligned in the distal and proximalbulkheads 94, 224 respectively along a top surface.

When the slide button 28 is moved distally to the jackhammer position,the sliding spur gear 218 disengages from the small spur gear 226 andengages a large spur gear 284 of a rotary camming gear assembly 286. Acamming shaft 286 from distal to proximal includes a distal cylindricalend 288, a cam wheel 290, a mid-shaft portion 292 that receives theupwardly directed strike pin 150 of the proximally projecting bolt 148,a wide diameter hub 294 that is encompassed by and pinned to the largespur gear 284, and a proximal cylindrical end 296. A distal cylindricalbearing 298 is received within a proximally open container 300projecting distally from the distal bulkhead 94 and in turn receives thedistal cylindrical end 288 of the camming shaft 286. A proximalcylindrical bearing 302 is received within a distally projecting andopen cylinder 304 formed on the proximal bulkhead 224 and in turnreceives the proximal cylindrical end 296 of the camming shaft 286.

As the camming shaft 286 rotates clockwise as viewed from behind, thecam wheel 290 presents a proximal surface to the distal edge of thestrike pin 150 that is more proximal until the interrupted portion ofthe camming wheel 290 is presented, allowing the strike pin 150 toreturn to a distal position under the urging of the distal biasing ofthe right and left compression springs 114, 118.

DISPOSABLE PROBE ASSEMBLY. In FIGS. 13-29, the disposable probe assembly14 has movable components that respond to the actuating motions of thereusable handpiece 12. With particular reference to FIGS. 13-15, thedistal portion 21 of the disposable probe assembly includes the probecannula 22 that is supported by the probe support body 60. The probesupport body 60 includes a distal probe mount 306 that is receivedwithin the distal probe mount cover 50 of the bottom cover 48. The frontcarriage 134 controls a vacuum valve 307. In particular, proximal to andunderlying a longitudinal axis of the disposable probe assembly 14defined by a probe guide hole 308 passing through the distal probe mount306, a vertically open longitudinal trough 310 is formed into a neckedportion 312 of the probe support body 60. A cutter carriage-drivenvacuum valve driver 313 has an elongate driver body 314 thatlongitudinally translates within the longitudinal trough 310 andupwardly presents an elongate slot 315 for being indirectly moved by thedownwardly projecting front actuation finger 206 of the front carriage136.

With reference also to FIG. 23, a proximal block portion 316 is attachedto the necked portion 312 of the probe support body 60. A lower mounting317 extends from the elongate driver body 314 distal to andlongitudinally aligned with a distally open, longitudinally alignedvacuum valve bore 318 (FIG. 23) formed in proximal block portion 316 ofthe probe support body 60. Central and proximal ports 320, 321communicate with the vacuum valve bore 318 from an underside of theproximal block portion 316 and a distal port 322 communicates laterallyfrom a right side of the proximal block portion 316. A right distal90-degree fitting 319 communicates between the distal port 322 and anintake filter 323 within an outer hose fitting 324.

A vacuum valve control rod 325 has a distal actuating portion 326extending distally out of the valve bore 318 with a distal endpositionable under the downwardly open portion of the longitudinaltrough 310 and attached to the lower mounting 317 of the vacuum valvedriver 313. The vacuum valve control rod 325 also has a valve spoolportion 327 that longitudinally translates within the valve bore 318 toselectively position between a first position and a second position. Aproximal O-ring 328 near a proximal end of the valve spool portion 327and a distal O-ring 329 are spaced such that the first position entailsthe O-rings 328, 329 bracketing the central and distal ports 320, 322and the second position entails the O-rings 328, 329 bracketing theproximal and central ports 321, 320, respectively.

The aft carriage 136 controls an air valve 351. In particular, an airvalve body 330 is attached to a left side of the proximal block portion316 and includes a distally open longitudinal air valve bore 331 (FIG.23) depicted in FIG. 14 as accessed by a distal left port 332, a leftcenter port 333, and a left proximal port 334. An air valve control rod335 has a distal actuating portion 336 extending distally out of the airvalve bore 331. The valve control rod 335 also has a valve spool portion337 that longitudinally translates within the air valve bore 331 toselectively position between a first position and a second position. Aproximal O-ring 338 near a proximal end of the valve spool portion 337and a distal O-ring 339 are spaced such that the first position entailsthe O-rings 338, 339 bracketing the central and distal ports 333, 332and the second position entails the O-rings 338, 339 bracketing theproximal and central ports 334, 333, respectively.

A valve connecting vacuum conduit 340 has one end attached to a lowercenter ninety-degree fitting 341 attached to the central port 320 of thevacuum valve bore 318 and the other end attached to an aft leftninety-degree fitting 342 that communicates with the left proximal port334 of the air valve bore 331. A distal conduit 343 is attached at oneend to a center ninety-degree fitting 344 that communicates with theleft center port 333 and at the other end at a probe union ninety-degreefitting 345 that communicates with the lateral lumen 44. A vacuum supplyconduit 346 is attached at one end to a distal ninety-degree fitting 347that communicates with the proximal port 321 and at the other end to avacuum supply (not shown). An air supply conduit 348 is attached at oneend to a distal ninety-degree fitting 349 that communicates with thedistal left port 332 and the other end to an air supply (not shown).

The front actuation finger 206 of the front carriage 136 (FIGS. 9-10) isreceived within an upwardly open socket 350 formed on a left side of acutter carriage-driven indexing shuttle 352 having a lateral concaverecessed band 354 shaped to encompass with a clearance a lower portionof the rotation spur gear section 68 of the cutter gear 62. An indexingarm 355 attached to the indexing shuttle 352 includes a proximallydirected portion that proximally terminates in a rightward portion thatterminates in an upward portion. In FIG. 14, a downwardly projectingvacuum actuator lug 356 (FIG. 14) attached to an underside of theindexing shuttle 352 is received within the elongate slot 315 of thevacuum valve driver 314 to selectively communicate the vacuum supply tothe probe cannula 22. An air shuttle 358 longitudinally rides on a leftedge of the necked portion 312 of the probe support body 60 and upwardlyprojects an air valve tab socket 360 positioned to receive the aftactuating finger 212 of the aft carriage 138. A downward mounting arm362 of the air shuttle 358 is attached to the distal actuating portion336 of the air valve control rod 335 extending distally out of the airvalve bore 331.

A straw hook wire 364 supports a midpoint of a sample retraction tube363 in place upon the probe support body 60 prior to engagement with thereusable handpiece 12. A curled lower right end passes into leftwardlyopening 365 along the top right surface of the proximal block portion316 of the probe support body 60 into a small mounting block 366extending upwardly from a right side with a downwardly inserted pin 368passing through the curled lower right end to hold the straw hook wire364 in place. The straw hook wire 364 has a horizontal portion attachedto the curled end that passes under the sample retraction tube 363,bending upward and then bending leftward and horizontally again througha lateral slot 370 in a vertical wire support member 372 formed onto aleft side of the top surface of the proximal block portion 316. Itshould be appreciated that engagement of the reusable handpiece 12forces the left portions of the straw hook wire 364 out of engagementwith the midpoint indented feature 350 as a rib feature 373 (FIG. 9)deflects the left portion of the straw hook wire 364. This facilitatescommonality with disposable probe assemblies in which the straw hookwire 364 keeps a translating sample retraction straw in place prior tomounting to the reusable handpiece 12 (not shown).

With particular reference to FIGS. 16-17, the sample revolver drumassembly 18 includes a revolver cylindrical drum 380 encompassed by adetachable revolver drum belt 382 that in turn holds removable samplevials 384 forming a revolver cylindrical drum assembly 386 (FIG. 20). Adrum base 388 includes a half cylinder recess 389 which holds the samplerevolver drum assembly 386 for rotation about the longitudinal axis andis closed by a top drum cover 390, which may be transparent formonitoring progress in tissue collection or opaque. An indexer supportbase 392 of the indexing assembly 19 has a proximal surface fastened toa distal surface of the drum base 388 and extends a mounting flange 394distally to attach to a proximal end of the hand-held distal portion 21of the disposable probe assembly 14. The sample retraction tube 363passes over the mounting flange 394 and is gripped within a longitudinalgroove 396 formed along a top, left side of the indexer support base 392and passes through a hole 398 on a top left corner of a distal face ofthe drum base 388.

A slotted distal drum axle 400 of the revolver cylindrical drum 380 isreceived within a smaller distal portion of the half cylinder recess 389and a proximal drum axle 401 (FIG. 21) is received within a smallerproximal portion of the half cylinder recess 389. The slotted distaldrum axle 400 receives an angled proximal end 402 of a shaft 404 thatpasses through a shaft hole 406 in the drum base 388. A distal portionof the shaft 404 is received within a shaft recess 408 across the top ofthe indexer support base 392 that communicates with a half cylindricalgear recess 410 that encompasses a lower half of a large bevel gear 412mounted on the shaft 404. A small half cylindrical gear recess 414receives a transversely oriented small bevel gear 416 that engages thelarge bevel gear 412. A transverse shaft 418 has a left end mounted tothe small bevel gear 416 and a right end mounted to a dual spur gearassembly 420 that rotates within a rightward transverse half cylindricalrecess 422 formed in the indexer support base 392.

With particular reference to FIG. 18, a top indexer gear cover 424mounts overtop of the indexer support base 392 that contacts the topsurfaces of the shaft 404 and left and right axle ends 426, 428 of thedual spur gear assembly 420 with a leftward slot 430 that exposes a topportion of the large bevel gear 412 and distally open left and rightvertical slots 432, 434 that expose top surfaces of a left and rightspur gear 436, 438 of the dual spur gear assembly 420. In FIG. 17-18, acentral beam 440, defined between the left and right vertical slots 432,434, has a T-shaped hold down spring 442 mounted on top with its narrowend 444 mounted to a proximal end of the central beam 440. A laterallywider end 446 extends overtop of both vertical slots 432, 434. A cyclicspring gate 448 extends laterally to the left and right from a proximalend of the T-shaped hold down spring 442 and ramps downwardly andproximally.

With particular reference to FIG. 18, each side of the central beam 440has a respective left and right lower pin guides 462, formed as an uppersurface of a wider lower portion. An upper pin guide 449 extendslaterally out from the central beam 440 on each side and is spacedrespectively above the lower pin guides 462, 470 to form a lower pinchannel 451. Although only the left upper pin guide 449 is depicted, itshould be appreciated that the right side includes a minor image upperpin guide. A rear ramped portion 453 of the upper pin guide 449underlies and supports the cyclic spring gate 448.

Left and right cyclic arms 450, 452 have distal ends mounted onrespective ends of a transverse cyclic axle 454 whose central portionpasses through a top end 456 of the index arm 355. Left fore and aftcyclic pins 458, 460 extend rightward out of the left cyclic arm 450.Right fore and aft cyclic pins 466, 468 extend leftward out of the rightcyclic arm 452. Each cyclic arm 450, 452 includes a respective left andright bottom rack segment 472, 474 close to the distal rotating endpositioned to engage a respective spur gear 436, 438 under the downwardurging of the laterally wider distal end 446 of the T-shaped hold spring442.

With reference to FIG. 16, the left cyclic arm 450 is at its distal mostposition. It should be appreciated that the left aft cyclic pin 460 isdistal to the upper pin guide 449. In FIG. 19A, proximal movement of theright cyclic arm 450 presents the rack segment 472 to rotate the leftspur gear 436 (not shown in FIG. 19A) top aft, held in engagement by theT-shaped hold down spring 442. Proximal movement of the cyclic arms 450,452 causes the dual spur gear assembly 420 and thus the small bevel gear416 to rotate top aft, which in turn causes the large bevel gear 412 andrevolver cylindrical drum assembly 386 to rotate top right, indexing thesample vial 384 to the sample retraction tube 363 in the hole 398. InFIG. 19B, the right cyclic arm 450 has reached its proximal mostposition, wherein the left aft pin 460 has pushed through the cyclicspring gate 448 and out of the lower pin channel 451. In FIG. 19C, upondistal movement of the right cyclic arm 450, the left aft pin 460 ridesup the cyclic spring gate 448, rotating the right cyclic arm 450 out ofengagement with the left spur gear 436. It should be appreciated thatthe left aft pin 460 will drop off of the front of the upper pin guide449 as the distal most position is reached and be positioned to enteragain the lower pin channel 451 under the downward urging the T-shapedhold down spring 442.

In FIGS. 20-22, the revolver cylindrical drum 380 includes radiallyspaced longitudinal recesses 476 shaped to receive respectivecylindrical vial holders 478 formed in the revolver drum belt 382 thathold the sample vials 384. Each vial holder 478 includes an elongateoutward aperture 480 so that contents of the retained vial 384 may beviewed. In order that pathology may ascertain which sample vial 384received the first and subsequent tissue samples, the revolver drum belt382 terminates in first and second belt retaining ears 482, 484 that aredrawn into longitudinal abutment and inserted into a longitudinalindexing and retention slot 486 formed in the revolver cylindrical drum380 as the circled revolver drum belt 382 is slid longitudinally ontothe revolver cylindrical drum 380. A V-shaped slot 488 of the slotteddistal drum axle 400 assures that the angled proximal end 402 of theshaft 404 is in an initial condition with a narrow aspect upward toreceive the open side of the V-shaped slot 488, which registers theretaining ears 482, 484 to a known position prior to commencingsampling.

In FIGS. 23-29, the operation of the reusable handpiece 12 and thehand-held distal portion 21 of the disposable probe assembly 14 aredepicted sequentially in diagrammatic form to illustrate how theindexing assembly 19 and revolver drum assembly 18 are operated inconjunction with the taking of vacuum assisted core biopsy samples. InFIG. 23, the hand-held distal portion 21 of the disposable probeassembly 14 has both carriages 134, 136 distally advanced in an initialstate for closing the side aperture 20 in the probe cannula 22 forinsertion into tissue. The front carriage 134 also advances the cuttercarriage-driven vacuum valve driver 313 to its distal position,switching the vacuum valve 307 distally to provide atmospheric pressureto the air valve 351 (i.e., atmosphere in distal port 322 and out centerport 320 to left proximal port 334). The aft carriage 136 positions theair valve 351 to shut off the input from the vacuum valve 307, insteadcausing the air supply conduit 348 to communicate through the leftdistal port 332 to the left center port 333 to the distal conduit 343 topressurize the lateral lumen 44.

In FIG. 24, the aft carriage 136 has proximally retracted, switching theair valve 351 so that the atmospheric pressure provided by the vacuumvalve 307 now communicates through the left proximal port 334 to theleft center port 334 to the distal conduit 343 to the lateral lumen 44,venting the probe cannula 22 to begin a new sample taking cycle.

In FIG. 25, the front carriage 134 has begun to proximally retract whilethe aft carriage 136 remains at its proximal most position. The cuttertube 36 retracts exposing a portion of the side aperture 20 of the probecannula 22 while the vacuum and air valves 307, 351 remain in the samestate with the probe cannula 22 vented to the atmosphere.

In FIG. 26, the front carriage 134 has reached its proximal mostposition, fully retracting the cutter tube 36 to expose the sideaperture 20 of the probe cannula 22, which is now under vacuum pressureto prolapse tissue by having the front carriage 134 position the vacuumvalve 307 to pass vacuum supply from the proximal port 321 through thecenter port 320 to the left central port 330 to the left distal port 332to the lateral lumen 44, drawing air through the internal vent holes 47.

In FIG. 27, the front carriage 134 has begun to distally advance,severing tissue, while the vacuum valve 307 remains switched to vacuumsupply and the air valve 351 remains in the state of passing the vacuumpressure through to the lateral lumen 44.

In FIG. 28, the front carriage 134 has been fully distally advanced,causing the cutter tube 36 to completely sever the prolapsed tissue intoa tissue sample and switching the vacuum valve 307 to vent to theatmosphere. With the aft carriage 136 still back, the air valve 351passes the atmospheric pressure to the lateral lumen 44 to vent theprobe cannula 46.

In FIG. 29, the aft carriage 136 has been distally advanced, switchingthe air valve 351 to pass air pressure from the left distal port 332 tothe left center port 333 to the lateral lumen 44. The increased airpressure passes through the holes 47 to the distal end of the cutterlumen 47 causing the tissue sample to be blown proximally back up thecutter tube 36 out of the distal hand-held portion 21 of the biopsydevice 10 into the sample revolver drum assembly 18.

The clinicians benefit from being able to visually or diagnosticallyimage the tissue samples while still being able to maintain the probecannula 22 in tissue to take additional samples, insert therapeuticagents, deposit a marker, etc. Thus, a minimum of reinsertions andverifications of position are necessary, yet the clinician is reassuredthat proper samples are being taken. Moreover, avoidance of biohazardsis provided by encasing the tissue samples for convenient transport forpathology assessment. Further, the individual storage allows correlatinga particular sample taken at a specific position in the patient'sbreast. In addition, the apparatus is portable with a minimum of neededinterconnections.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein, will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art, giventhe benefit of the present disclosure, that such embodiments areprovided by way of example only. Numerous variations, changes, andsubstitutions will now occur to those skilled in the art withoutdeparting from the spirit and scope of the appended claims.

For example, while a rotating drum assembly provides an efficient meansto capture a plurality of tissue samples, applications consistent withthe present invention may include an uncircled belt that is drawn into aproximal portion of a biopsy device and then indexed to a next samplecontainer with the filled sample containers on the belt moved out.

As another example, while automatically registering the next of aplurality of sample containers (e.g., vials) provides an efficient wayof segregating tissue samples, applications consistent with the presentinvention may selectively uncouple the indexing of the next samplecontainer. Instead, a manual selection may be made when the next samplecontainer is to be positioned to receive the next sample. Alternatively,a separate control may be selected for the motor to drive the indexingarm or similar reciprocating element.

As another example, while a sample revolver drum assembly attached formovement with the proximal portions of the biopsy device has certainadvantages, applications consistent with the present invention mayinclude a revolver drum assembly coupled by flexible attachments, suchas communicating a flexible drive capable for indexing motion.

As yet another example, while a detachable belt and detachable samplevials provide clinical flexibility, it should be appreciated thatapplications consistent with the present invention may include vials orsimilarly shaped sample containers that are immovably attached to a beltor a rigid outer cylinder wall structure.

As yet a further example, while a mechanical linkage is described hereinfor automatically indexing the samples, it should be appreciated thatelectromechanical positioning and control may be employed to sequencingsample storage.

1. A biopsy device, comprising: (a) a body; (b) an elongate memberextending distally from the body, the elongate member having atransverse tissue receiving feature; (c) a cutter movable relative tothe elongate member to sever tissue protruding into the transversetissue receiving feature, wherein the cutter defines a lumen, whereinthe lumen of the cutter defines a first longitudinal axis; and (d) atissue sample holder coupled with the body, wherein the tissue sampleholder comprises a rotatable member having an exterior portion and adrum axle defining a second longitudinal axis, wherein the rotatablemember is rotatable about the second longitudinal axis, wherein theexterior portion comprises a plurality of recesses, wherein each recessof the plurality of recesses comprises a semi-circular face and at leastone transverse open portion relative to the second longitudinal axis,wherein the rotatable member is rotatable relative to the body toselectively associate each recess with the lumen of the cutter.
 2. Thebiopsy device of claim 1 wherein the rotatable member is operableselectively rotate a recess of the plurality of recesses to a positionrelative to the tissue sample holder such that a tissue sampleassociated with the recess is viewable via the open portion of therecess.
 3. The biopsy device of claim 1 wherein the second longitudinalaxis is parallel to the first longitudinal axis, wherein the rotatablemember is rotatable to successively index each recess relative to thelumen of the cutter.
 4. The biopsy device of claim 3 further comprisingan indexing assembly in communication with the rotatable member, whereinthe indexing assembly is operable to rotate the rotatable member toselectively index each recess relative to the lumen of the cutter. 5.The biopsy device of claim 4 further comprising a reusable handpiece,wherein the indexing assembly engages with at least a portion of thehandpiece, wherein the body is selectively coupleable to the handpiece.6. The biopsy device of claim 1 wherein the drum axle comprises anindexing feature, wherein the indexing feature is associated with anangular position of the rotatable member relative to the body.
 7. Thebiopsy device of claim 1 wherein each recess of the plurality ofrecesses is sized to receive at least one tissue sample.
 8. The biopsydevice of claim 1 wherein the tissue sample holder further comprisescover portion associated with the rotatable member.
 9. The biopsy deviceof claim 7 wherein the cover portion is transparent.
 10. The biopsydevice of claim 1 wherein the cutter is slidably disposed within theelongate member, wherein the cutter is translatable and rotatablerelative to the elongate member.
 11. The biopsy device of claim 1further comprising a needle tip coupled to a distal end of the elongatemember.
 12. The biopsy device of claim 1 wherein the plurality ofrecesses are equally spaced about the circumference of the rotatablemember.
 13. The biopsy device of claim 1 wherein the tissue sampleholder is selectively coupled with the body.
 14. The biopsy device ofclaim 1 wherein each recess of the plurality of recesses is operable tocarry at least one tissue sample.
 15. The biopsy device of claim 1wherein the tissue sample holder further comprises a base and a cover,wherein the base and the cover enclose the rotatable member therein. 16.A biopsy device comprising: (a) a handpiece portion; (b) a probe bodydetachably coupled to the handpiece portion; (b) an elongate memberextending distally from the probe body, the elongate member having atransverse tissue receiving feature; (c) a cutter movable relative tothe elongate member to sever tissue protruding into the transversetissue receiving feature, wherein the cutter defines a lumen, whereinthe lumen of the cutter defines a first longitudinal axis; and (d) atissue sample holder coupled with the probe body, wherein the tissuesample holder comprises a rotatable member having an exterior portion,wherein the exterior portion comprises a plurality of radially inwardlydirected recesses, wherein each recess comprises at least one transverseopen portion, wherein the rotatable member is rotatable relative to theprobe body to selectively associate each recess with the lumen of thecutter.
 17. The biopsy device of claim 16 wherein each recess of theplurality of radially inwardly directed recesses is configured toreceive a longitudinally oriented tissue sample.
 18. The biopsy deviceof claim 16 wherein each recess of the plurality of radially inwardlydirected recesses is operable to carry at least one tissue sample. 19.The biopsy device of claim 16 wherein the rotatable member is rotatableto successively index each recess relative to the lumen of the cutter.20. A biopsy device comprising: (a) a handpiece portion; (b) a probebody detachably coupled to the handpiece portion; (b) an elongate memberextending distally from the probe body, the elongate member having atransverse tissue receiving feature; (c) a cutter movable relative tothe elongate member to sever tissue protruding into the transversetissue receiving feature, wherein the cutter defines a lumen, whereinthe lumen of the cutter defines a first longitudinal axis; and (d) atissue sample holder coupled with the probe body, wherein the tissuesample holder comprises: (i) a rotatable member having an exteriorportion and defining a second longitudinal axis, wherein the rotatablemember is rotatable about the second longitudinal axis, wherein theexterior portion comprises a plurality of recesses, wherein each recessof the plurality of recesses comprises a semi-cylindrical face and atleast one transverse open portion relative to the second longitudinalaxis, wherein the rotatable member is rotatable relative to the probebody to selectively associate each recess with the lumen of the cutter,and (ii) a cover portion associated with the rotatable member, whereinthe cover portion is transparent, wherein at least one recess is visiblethrough the cover portion.